PROTEOR FS3 Highlander Max Foot Instruction Manual

: June 12, 2024
: PROTEOR

HIGHLANDER® & HIGHLANDER® MAX
FS3 & FS3-H5

PROTEOR FS3 Highlander Max Foot - Cover

Instruction for use

FS3 Highlander Max Foot

| Highlander® & Highlander® MAX – FS3 & FS3-H5
Instructions for use for prosthetists
Read before use| IFU-01-015
Rev. A
2023-02
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Pass on § 12, 13, 14, 15, 16, 17 and 18 of these instructions to the patient.

INCLUDED ITEMS

Part description	Part number	Included / Sold separately
Highlander Foot with regular toe	FS3-00-0xAyy-RU*	Included
Highlander Foot with sandal toe, right	FS3-00-0xAyy-SR*
Highlander Foot with sandal toe, left	FS3-00-0xAyy-SL*
Highlander MAX Foot with regular toe	FS3-H5-xxAyy-RU*
Highlander MAX Foot with sandal toe, right	FS3-H5-xxAyy-SR*
Highlander MAX Foot with sandal toe, left	FS3-H5-xxAyy-SL*
Black Spectra sock	SO-NPS-200zz-00*	Suitable sock included
Stiffening bumpers	KIT-00-1130U-00	Included
Foot Shell Removal Tool	ACC-00-10300-00	Sold separately
Foot shell with regular toe (no cap)	FTC-3M-1	Sold separately

xx = Category, yy = Size (see table §3), zz = Size

DESCRIPTION

Highlander® and Highlander® MAX are energy-return prosthetic feet consisting of:

A carbon keel
A carbon sole plate
A male pyramid connection
A Spectra sock

Available with regular toe or right or left sandal toe and delivered with a set of elastomer stiffening bumpers.

PROPERTIES

Foot	Highlander — FS3	Highlander MAX — FS3-H5
Side	Right or Left
Size	22 to 25 cm	26 to 28 cm
Sandal toe option	Yes	Yes
Weight*	436 g / 1.0 lbs	538 g / 1.2 lbs

859 g / 1.9 lbs
Build height*| 97 mm / 3.8″| 110 mm / 4.3″| 118 mm / 4.6″| 111 mm / 4.4″| 121 mm / 4.8″
Heel height| 10 mm P/8″

*Based on sizes 23, 26, 29, cat. 4 (for Highlander) and cat.10 (for Highlander MAX), with foot shell, Spectra sock and 10 mm heel height

Highlander has been tested according to ISO 10328 for a maximum patient weight up to 166 kg for 2 million cycles.

Selection of foot category based on patient s weight and activity level — Highlander

Weight*)| lbs| 100-115| 116-130| 131-150| 151-170| 171-195| 196-220| 221-255| 256-285| 286-325| 326-365
kg| 44-52| 53-59| 60-68| 69-77| 78-88| 89-100| 101-116| 117-130| 131-147| 148-166
Activity
level| Low| 1| 1| 2| 3| 4| 5| 6| 7| 8| 9
Moderate| 1| 2| 3| 4| 5| 6| 7| 8| 9|
High| 2| 3| 4| 5| 6| 7| 8| 9| |

*) Body mass limit not to be exceeded (ISO 10328)

Highlander MAX has been tested according to ISO 10328 for a maximum patient weight up to 226 kg for 2 million cycles.

Selection of foot category based on patient’s weight and activity level — Highlander MAX

Weighty| lbs| 286-325| 326-365| 366-418| 419-478| 479-500
kg| 131-147| 148-166| 167-190| 191-217| 218-226
Activity level| Low| | –| 10| 11| 12
Moderate| –| 10| –| –|
High| 10| 11| –| –| –

*) Body mass limit not to be exceeded (ISO 10328)

MECHANISM OF ACTION

During the strike phase, the sole and heel store energy, which they return in the middle of the stance phase. This property creates the impetus enabling the forefoot to accumulate energy and return it upon the step completion.

INTENDED USE/INDICATIONS

These medical devices are supplied to healthcare professionals (prosthetists), who will train the patient in their use.
The prescription is drawn up by a doctor who assess the patient’s ability to use the foot.
These devices are for multiple use on a SINGLE PATIENT. They must not be used on another patient.
These devices are intended to be integrated in a custom-made external lower limb prosthesis to ensure the function of the foot in patients with unilateral or bilateral lower limb amputation and/or congenital limb deficiency.
These devices are indicated for patients with moderate activity level (K3) for walking and physical activities without excessive overload.

Highlander maximum weight (load carrying included): 166 kg / 365 lbs
Highlander MAX maximum weight (load carrying included): 226 kg / 500 lbs
(See table §3)

CLINICAL BENEFITS

Walking comfort
Reduction of joint impacts
Stability on variable terrain
Possible walking on uneven ground

ACCESSORIES AND COMPATIBILITY

An appropriate foot shell must be mounted on the foot module (see our catalogue).
The foot includes a male pyramid connection designed to be compatible with standard female pyramid connectors (see our catalogue).

ALIGNMENTS

Bench Alignment
Before installing the prosthesis on the patient:

Align the foot module in plantar/dorsi flexion, by inserting the foot (with foot shell) into the shoe to account for the heel height
Align the socket in adduction/abduction, to ensure an appropriate angle in the frontal plane
Align the socket in flexion/extension, to ensure an appropriate angle in the sagittal plane
Adjust the position of the socket so that the load line falls to the anterior dome of the pyramid (see illustration)

Dynamic Alignment
To optimize roll-over from heel to forefoot, adjust the following variables:

Foot position in the anterior/posterior plane
Plantar/dorsi flexion
Heel flexibility

The dynamic alignment is performed in accordance with good professional practices.

ASSEMBLY

Highlander feet are pre-assembled and consist of a foot module, a Spectra sock, and a foot shell. After dynamic alignment, tighten the pyramid adjustment screws according to the specifications of the connector manufacturer. Secure pyramid adjustment screws with a thread locking adhesive (i.e., Loctite 242).

Spectra sock
A Spectra sock is included to protect the foot shell and minimize noise. It must be placed on the foot module before mounting the foot shell.

Foot shell
To install and remove the foot shell, use the foot shell removal tool to prevent damage of the foot module.
Never remove the foot from the foot shell by pulling manually. This could damage the foot.

ADJUSTMENTS

The heel stiffness at foot loading can be adjusted using the stiffening bumpers. The bumpers may be temporarily attached using the pre-applied adhesive in the location indicated in the table below. The recommended location will stiffen the heel of about 1 category. If necessary, move the bumpers anteriorly (stiffer) or posteriorly (softer) to get the desired stiffness. For permanent placement, clean off the pre-applied adhesive with acetone and adhere bumpers using cyanoacrylate glue.

Foot size
(A)| Distance from the rear end
of the sole (B)| | PROTEOR FS3 Highlander Max Foot - ADJUSTMENTS
2
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22-25 cm| 32 mm / 1,25’’
26-28 cm| 38 mm / 1,5’’
29-31 cm| 48 mm / 1,9’’

TROUBLESHOOTING

CONCERN	SYMPTOM	SOLUTION
Heel too soft	• Foot flat occurs too fast

• Toe feels excessively stiff
• Knee hyperextension| • Shift socket anteriorly in relation to the foot
• Attach stiffening bumpers. See section 10 above for installation details
Heel too hard| • Rapid knee flexion, instability
• Heel to toe progression too fast
• Lack of energy return sensation| • Shift socket posteriorly in relation to the foot
• Verify appropriate foot module category
Foot module too stiff| • Flat spot in rollover motion at slow cadences| • Consider a lower category foot module
Foot module too soft| • Clicking noise at initial contact
• Excessive toe deflection during high impact activity| • Consider a higher category foot module

WARNINGS

In case of damaged packaging, check the integrity of the device.
Never use the foot without a foot shell.
Never loosen the pyramid fastening screws.
The patient must inform their prosthetist if they gain or lose significant weight.
Always use the foot with a sock and shoe. Failure to adhere to this advice may cause product failure, as well as serious injury.
Make sure that the foot and inside of the foot shell are free of impurities (e.g., sand). The presence of impurities causes the graphite parts to wear out. Clean the foot according to the instructions (see §16).
After swimming, using in water or if splashed by a liquid, the foot must be cleaned (see §16).
If the patient notices any abnormal behavior or feel any changes in the characteristics of the device (noise, play, excessive wear…), or if the device has received a severe impact, they should stop using the device and consult their prosthetist.
Failure to follow the instructions for use is dangerous and will void the warranty.

CONTRAINDICATIONS

Use for a patient whose maximum weight (load carrying included) may exceed 166 kg / 365 lbs for Highlander and 226 kg / 500 lbs for Highlander MAX
Use for activities associated with a risk of significant impact or excessive overloading

SIDE EFFECTS

There are no known side effects directly associated with the devices.
Any serious incident that has occurred in relation to the devices should be reported to the manufacturer and to the competent authority of the Member State in which the user is established.

MAINTENANCE AND CONTROL

The foot module must be inspected by the prosthetist at least every six months. Inspections at shorter intervals are required if the user is more active.
The Spectra sock and the foot shell must be replaced by the prosthetist at regular intervals, depending on the patient’s level of activity. If these parts are damaged, it can lead to premature foot wear.
The lifetime of the foot depends upon the patient’s level of activity.

CLEANING

Remove the foot shell and the Spectra sock, clean the foot with clear water and neutral soap and dry carefully.
The foot shell can be cleaned with a damp cloth or sponge.

ENVIRONMENTAL CONDITIONS

Temperature range for use and storage: -20 to 60°C
Relative air humidity: no restrictions
Water-resistant: the device is resistant to occasional immersion and splashes.

DISPOSAL

The feet are made of carbon fiber composite, epoxy, PU polymers, titanium, and stainless steel. The devices and their packaging must be disposed of in accordance with local or national environmental regulations.

DESCRIPTION OF THE SYMBOLS

| Manufacturer
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| Authorized representative in the European Union
| Identified risk
| Single patient, multiple use
| CE marking and year of
1st declaration